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FDA Guidance Looks to Advance Use of Drug Development Tools in Trials

A new guidance from the U.S. Food and Drug Administration (FDA) offers the agency’s latest thinking on the qualification process for drug development tools (DDTs), defined as the methods, materials, or measures that can aid drug development and regulatory review. “Encouraging the identification and use of reliable DDTs can significantly advance the development of […]

ACRP Advocates for Role of Clinical Research Workforce in Cures 2.0 Development

While 2016’s landmark 21st Century Cures Act is successfully advancing medical research and inspiring a new era of medical innovations, a rare bipartisan effort on Capitol Hill dubbed “Cures 2.0” is looking to build and expand on that work. At its core, Cures 2.0 is an effort to modernize coverage of and access to life-savings […]

Together, We are Making History

Clinical Researcher—December 2019 (Volume 33, Issue 10) CHAIR’S MESSAGE John P. Neal, CRCP   Historians like to use certain years as shorthand. For example, in American history, citing the years 1776, 1929, and 1945 immediately conjure up important images and turning points regarding independence, economic collapse, and a world war victory, respectively. It’s not my […]

The Hits Just Keep Coming

Clinical Researcher—December 2019 (Volume 33, Issue 10) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas   As we wait for the giant ball to drop in New York’s Times Square, it’s only natural to reflect on the year ending in just a few weeks. Here at ACRP, we’re excited about what has transpired over the past 12 months, […]

Katharine York, BS, Senior Clinical Systems Analyst, Rho

Human Factor Ultimately Determines Success or Failure in Technology Rollouts

Don’t let the technology itself sidetrack you when mulling and implementing a big technology upgrade. Success or failure ultimately comes down to skillfully navigating the most basic human factors of communication and inspiration, according to a group of industry experts with a proven track record of success at Rho. “One of the most important things […]